A Randomized, Double Blind, Multicenter, Prospective ClinicalStudy to Evaluate the Efficacy, Safety of Test Formulations in Improving BoneHealth in Subjects with Low Bone Mass.

ITC Life Sciences and Technology Centre0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

阶段: 未知
状态: 尚未招募
发起方

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

入选标准

•1. Subjects with low bone mass (BMD, T- score of -1 to -2.5 SD)
•2. Subjects willing to follow the procedures as per the study protocol and voluntarily sign an informed consent form

排除标准

•1. History of any illness affecting bone metabolism like renal failure, hepatic failure, active malignancy,
•hyperthyroidism or hyper parathyroidism
•2. Pregnant or lactating women.
•3. Female patient of child bearing potential who do not agree to remain abstinent or use medically acceptable methods of contraception during the study treatment and for 4 weeks after the end of treatment.
•4. Subjects with
•Alkaline phosphatase more than twice the upper limit of normal, Liver disease (SGOT or SGPT more than twice the upper limit of normal),Kidney disease (creatinine >2.0 mg/dL)
•Hypercalcemia (calcium >10.5 mg/dL)
•5. Uncontrolled chronic disorders that could affect bone metabolism (liver disease, alcoholism, primary hyperparathyroidism, or malignancy)
•6. Pharmacotherapy for osteoporosis (except calcium or vitamin D) in the previous 3 months
•7. Injection of an agent for osteoporosis in the previous 6 months
•8. Systemic administration of an agent that may affect calcium metabolism in bone, such as a systemic corticosteroid or diuretic, for more than 6 months (subjects who have not received forbidden drugs except contraceptive injections within the previous 3 months before screening may be eligible to
•participate)
•9. Metabolic bone diseases other than osteoporosis
•10. A mental disorder likely to affect compliance with the requirements of the trial
•11. Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study
•12. Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study.

研究者

发起方

ITC Life Sciences and Technology Centre

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